The present invention relates to an apparatus and a method for sealing a puncture in a tubular tissue structure or the wall of a body cavity. More particularly, the present invention is directed to sealing a puncture site with submucosal tissue or another extracellular matrix-derived tissue capable of remodeling endogenous connective tissue.
The control of bleeding during and after surgery is important to the success of the procedure. The control of blood loss is of particular concern if the surgical procedure is performed directly upon or involves the patient""s arteries and veins. Well over one million surgical procedures are performed annually which involve the insertion and removal of catheters into and from arteries and veins. Accordingly, these types of vasculature procedures represent a significant amount of surgery in which the control of bleeding is of particular concern.
Typically, the insertion of a catheter creates a puncture through the vessel wall and upon removal the catheter leaves a puncture opening through which blood may escape and leak into the surrounding tissues. Therefore, unless the puncture site is closed clinical complications may result leading to increased hospital stays with the associated costs. To address this concern, medical personnel are required to provide constant and continuing care to a patient who has undergone a procedure involving an arterial or venous puncture to insure that post-operative bleeding is controlled.
Surgical bleeding concerns can be exacerbated by the administration of a blood thinning agent, such as heparin, to the patient prior to a catheterization procedure. Since the control of bleeding in anti-coagulated patients is much more difficult to control, stemming blood flow in these patients can be troublesome. A common method of healing the puncture to the vessel is to maintain external pressure over the vessel until the puncture seals by natural clot formation processes. This method of puncture closure typically takes about thirty to ninety minutes, with the length of time usually being greater if the patient is hypertensive or anti-coagulated.
Furthermore, it should be appreciated that utilizing pressure, such as human hand pressure, to control bleeding suffers from several drawbacks regardless of whether the patient is hypertensive or anti-coagulated. In particular, when human hand pressure is utilized, it can be uncomfortable for the patient, can result in excessive restriction or interruption of blood flow, and can use costly professional time on the part of the hospital staff. Other pressure techniques, such as pressure bandages, sandbags, or clamps require the patient to remain motionless for an extended period of time and the patient must be closely monitored to ensure the effectiveness of these techniques.
Other devices have been disclosed which plug or otherwise provide an obstruction in the area of the puncture (see, for example, U.S. Pat. Nos. 4,852,568 and 4,890,612) wherein a collagen plug is disposed in the blood vessel opening. When the plug is exposed to body fluids, it swells to block the wound in the vessel wall. A potential problem with plugs introduced into the vessel is that particles may break off and float downstream to a point where they may lodge in a smaller vessel, causing an infarct to occur. Another potential problem with collagen plugs is that there is the potential for the inadvertent insertion of the collagen plug into the lumen of the blood vessel which is hazardous to the patient. Collagen plugs also can act as a site for platelet aggregation, and, therefore, can cause intraluminal deposition of occlusive material creating the possibility of a thrombosis at the puncture sight. Other plug-like devices are disclosed, for example, in U.S. Pat. Nos. 5,342,393, 5,370,660 and 5,411,520.
Accordingly, there is a need for surgical techniques suitable for sealing punctures in a tubular tissue structure or in the punctured wall of a body cavity, such as a heart chamber, or a body cavity of another organ. Such techniques require rapid, safe, and effective sealing of the puncture. It would also be advantageous to close the puncture without disposing any occlusive material into the vessel or body cavity, and without introducing infectious organisms into the patient""s circulatory system.
The present invention is directed to an apparatus and method for sealing punctured tubular tissue structures, including arteries and veins, such as punctures which occur during diagnostic and interventional vascular and peripheral catheterizations, or for sealing a puncture in the wall of a body cavity. More specifically, the apparatus and method of the present invention employ submucosal tissue or another extracellular matrix-derived tissue to seal punctures in tubular tissue structures, such as blood vessels, or in the wall of a body cavity. The submucosal tissue or other extracellular matrix-derived tissue is capable of inducing tissue remodeling at the site of implantation by supporting the growth of connective tissue in vivo, and has the added advantages of being tear-resistant so that occlusive material is not introduced into the patient""s circulatory system. Also, submucosal tissue or another extracellular matrix-derived tissue has the advantage of being resistant to infection, thereby reducing the chances that the procedure will result in systemic infection of the patient.
In one embodiment, a method of sealing a puncture site in the wall of a tubular tissue structure is provided. The method comprises the step of inserting submucosal tissue of a warm-blooded vertebrate into the puncture site.
In another embodiment a method of sealing a puncture site in the wall of a body cavity is provided. The method comprises the step of inserting submucosal tissue of a warm-blooded vertebrate into the puncture site.
In an alternate embodiment a method of sealing a puncture site in the wall of a tubular tissue structure is provided. The method comprises the step of inserting an intact extracellular matrix-derived tissue of a warm-blooded vertebrate into the puncture site.
In another embodiment a method of sealing a puncture site in the wall of a body cavity is provided. The method comprises the step of inserting an intact extracellular matrix-derived tissue of a warm-blooded vertebrate into the puncture site.
In another embodiment, a method of sealing a puncture site in the wall of a tubular tissue structure or in the wall of a body cavity is provided. The method comprises the steps of (a) inserting an introducer element into the puncture site, the introducer element having a sheet comprising submucosal tissue or another extracellular matrix-derived tissue of a warm-blooded vertebrate, the sheet having a user distal end and a user proximal end, wherein the proximal end of the sheet remains outside of the punctured wall and the distal end of the sheet is inserted into the tubular tissue structure or the body cavity, and wherein the sheet has at least one tether for positioning the distal end relative to the puncture site, (b) pulling the tether to position the distal end of the sheet relative to the puncture site, and (c) pulling the tether to position the distal end of the sheet within the puncture site.
In yet another embodiment an apparatus for sealing a puncture site in the wall of a tubular tissue structure or in the wall of a body cavity in a patient is provided. The apparatus comprises an introducer element and a sheet of submucosal tissue or another extracellular matrix-derived tissue on the introducer element, the sheet having a user distal end and a user proximal end.
In an alternate embodiment, a tissue graft for sealing a puncture site in the wall of a tubular tissue structure or in the wall of a body cavity is provided. The tissue graft comprises submucosal tissue or another extracellular matrix-derived tissue and at least one tether attached to the tissue graft.
In another embodiment, an apparatus for sealing a puncture site in the wall of a tubular tissue structure or in the wall of a body cavity in a patient is provided. The apparatus comprises an introducer element, a positioning tube positioned on the introducer element, to provide at least one lumen for containing a retaining tether, a sheet of submucosal tissue or another extracellular matrix-derived tissue positioned on the positioning tube, the sheet having a user distal end and a user proximal end, and at least one tether attached at or near the distal end of the sheet for positioning the distal end of the sheet relative to the puncture site.
In still another embodiment, an apparatus for containing a tether is provided. The apparatus comprises a tubular spacer element for positioning on an introducer element, the spacer element having an inner surface and an outer surface, and at least one ridge on the inner surface of the spacer element to prevent the inner surface of the spacer element from contacting the introducer element to provide at least one lumen for containing the tether.
In another embodiment, an apparatus for containing a tether is provided. The apparatus comprises a tubular spacer element having an inner surface, an outer surface, and at least one lumen positioned between the inner and outer surfaces to provide at least one lumen to contain the tether.
In yet another embodiment a kit is provided. The kit comprises an introducer element and a sheet of submucosal tissue or another extracellular matrix-derived tissue.